Hoechst reportedly stalls RU-486 in U.S.

May 16, 1994|By Chicago Tribune

WASHINGTON -- Despite the Clinton administration's solicitous attitude toward RU-486, efforts to make the so-called abortion pill widely available have been stalled for months by the manufacturer's fears of a backlash from abortion foes.

One of President Clinton's first acts was to move to lift the U.S. ban on the French-invented drug, which serves as a licensed alternative to surgical abortion in Britain, France and Sweden.

He ordered Secretary of Health and Human Services Donna E. Shalala to begin proceedings to get RU-486 licensed and manufactured in this country as quickly as possible.

But after 13 months of negotiations, the administration's efforts have been stymied by AG Hoechst of Germany, owner of the French company Roussel Uclaf that holds the patent on the drug.

Hoechst, a publicly traded company, is resisting efforts to introduce RU-486 here, apparently out of concern that anti-abortion forces would wage a boycott against its products, which include textiles, rug fibers and drugs for diabetics and heart patients. Hoechst subsidiaries have annual U.S. sales of $7 billion.

In April 1993, Roussel Uclaf raised hopes that RU-486 would be made available quickly in the United States when it agreed to transfer its patent on the drug to the Population Council, a nonprofit research organization in New York.

The council, in turn, pledged to find a domestic manufacturer to produce RU-486 and to conduct the clinical trials necessary to get Food and Drug Administration approval to sell it here.

Since then, observers of the discussions said, Hoechst has raised obstacle after obstacle in negotiations toward a formal agreement with the Population Council, seeking unusually broad assurances that it would be protected from potential product liability suits or losses from anti-abortion demonstrations.

Health and Human Services officials, while not directly involved in the discussions, have attempted from the sidelines to prod them along, with little success.

"It has been a long time," Sandra Waldman, spokeswoman for the Population Council, said of the negotiations. "I don't think anyone expected it to take this long."

"It's outrageous," said Rep. Ron Wyden, D-Ore., who has accused Hoechst of foot-dragging. Mr. Wyden has scheduled a hearing before a congressional subcommittee today to investigate the delays.

Supporters of the drug were hoping last week that the threat of tough questioning by Congress would prompt Hoechst officials toward a quick resolution.

"We thought [the arrangement between Hoechst and the Population Council] would lead to testing of RU-486 by the end of 1993. Here we are working our way toward the middle of 1994, and the testing program has still not begun," Mr. Wyden said. "I'm angry."

While feminist groups are eager to see U.S. women presented with an option to surgical abortion, medical experts say RU-486 also may be useful in treating breast cancer, certain brain tumors and other diseases.

Eleanor Smeal, president of the Fund for the Feminist Majority, said that if the logjam wasn't broken, feminist groups would pressure the government to rescind Roussel Uclaf's patent or fund development of a similar drug.

"Medical research has been slowed, and women's medical well-being injured. That [Hoechst officials] have held up this drug for several years for economic or political reasons is an outrage," Ms. Smeal said. "If it can be done on this drug, then it can be done on other drugs."

Meanwhile, administration officials and members of Congress who support RU-486 are acknowledging the difficulty in trying to force the hand of a foreign-based company.